Janssen Releases Long-Term AMBER Trial Data Supporting Safety, Efficacy of Symtuza for HIV

October 30, 2018

Building on positive 48-week data, Janssen released 96-week data demonstrating high rates of virogolic suppression and tolerability among antiretroviral therapy-naïve adults with HIV-1.

In July, the FDA approved Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg), the first darunavir-based single-tablet treatment regimen for HIV, and earlier this month, study findings presented at the 2018 Infectious Disease Week conference confirmed that the treatment regimen both results in and maintains high virologic suppression rates.

Now, adding to the literature on Symtuza’s efficacy, Janssen announced positive, extended data from the AMBER trial—one of the 2 phase 3 trials that led to the treatment’s approval. Building on week 48 data, the new, 96-week data demonstrates sustained high rates of virologic suppression and tolerability in antiretroviral therapy-naïve adults with HIV-1.

Among the 362 patients, 85% (308) achieved virologic suppression at 96 weeks, and there was a low virologic failure rate (6%, 20). No patients demonstrated darunavir, primary protease inhibitor, or tenofovir resistance-associated mutations.

“As previously reported, only 1 patient receiving Symtuza developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation through week 48,” noted the press release. “In the current analysis through 96 weeks, only 1 additional patient receiving Symtuza developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation to emtricitabine.”

The treatment was well-tolerated among patients, with 3% (11) experiencing adverse event-related discontinuations over the 96 weeks and 3% (10) experiencing a grade 3 or 4 study drug-related adverse event. The most commonly observed drug-related adverse events during the extension period were diarrhea, rash, and nausea. The bone, renal, and lipid safety results were consistent with known tenofovir and alafenamide and cobicistat profiles.

“This 96-week AMBER data further demonstrate the importance of Symtuza as a treatment option for adults new to HIV therapy who may benefit from a single-tablet regimen that offers the protective barrier to resistance of darunavir along with the tolerability profile of tenofovir alafenamide,” said Joseph Eron, MD, professor of medicine and director, clinical core, University of North Carolina Center for AIDS Research, in a statement.

Currently, HHS guidelines recommend darunavir-based treatments when clinicians don’t have all genetic resistance test results, when a patient may be at risk for suboptimal adherence, or in rapid initiation scenarios.

In addition to demonstrating safety and efficacy in antiretroviral therapy-naïve adults, Symtuza has also shown to be effective in previously treated patients. During the 2018 Infectious Disease Week, 96-week data from the EMERALD trial, which, together with the AMBER trial, led to Symtuza’s approval, supported the safety and efficacy of switching from boosted protease inhibitor (BPI)-based regimens to Symtuza, regardless of prior treatment regimens in the patient population.

Following week 48, patients could continue on Symtuza or switch from the BPI-based regimen to Symtuza at week 52. Over the 44 weeks, 2.3% of patients in the late switch cohort experienced virologic rebound, but many of these rebounders were resuppressed by week 96. By week 96, 90.7% of patients who continued on Symtuza were virally suppressed and 93.8% of those in the late switch cohort had maintained virologic suppression.